Is the WHO Recommended Dose of Pralidoxime Effective in t... | NCT02040350

Studies
Is the WHO Recommended Dose of Pralidoxime Effective in the Treatment of Organophosphorus Poisoning?

NCT02040350

Sponsor

Sheri Kashmir Institute of Medical Sciences

Status

Completed

Last Update Posted

Jan 20, 2014Estimated

Enrollment

100Actual

Phase

Phase 1

Conditions

Deaths

Interventions

Pralidoxime

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Jan 9, 2014

First Submission Date that Met QC Criteria

Jan 16, 2014

First Posted Date

Jan 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2014

Last Update Posted Date

Jan 20, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tariq Wani, Registar, Sheri Kashmir Institute of Medical SciencesPrincipal Investigator

Lead Sponsor

Sheri Kashmir Institute of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the effectiveness of Pralidoxime, a drug used for treatment of pesticide poisoning (Organophosphorous poisonings)

Detailed Description

The present study was designed to critically analyze the role of pralidoxime in patients with moderate to severe poisoning by dividing them into two comparable groups in all aspects and using WHO recommended dose of pralidoxime (30mg/kg bolus I.V over 20 min followed by 8mg/kg/hr continuous infusion). This dose and continuous infusion protocol is more likely to maintain adequate blood concentrations of pralidoxime throughout 24 hours and thus would avoid any failures in effectiveness of pralidoxime because of inconsistent blood levels.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo was given to compare the effects	Drug: Pralidoxime
Pralidoxime	Active Comparator	Pralidoxime for treating organophosphorous poisoning patients	Drug: Pralidoxime

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pralidoxime	Drug	Pralidoxime was compared to placebo to study the effects of the drug on mortatlity	Placebo Pralidoxime

Measure	Description	Time Frame
mortality rate		upto one year

Measure	Description	Time Frame
duration of ventilation		upto one year

Measure	Description	Time Frame
duration of ICU stay		upto one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

history of alleged organophosphorus intake age > 14 years < 60 years clinical signs and symptoms of organophosphorus poisoning.

Exclusion Criteria:

< 14 years or > 60 years of age known pregnancy pralidoxime administration at the transferring hospital carbamate poisoning any chronic illnesses

≥ 12 hour interval from time of poisoning to initiation of treatment pre-hospital cardiac or respiratory arrest.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Showkat Gurcoo, MD	SKIMS	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheri kashmir insititute of medical sciences		Srinagar	Srinagar Kashmir	190006	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17706760	Background	Eddleston M, Buckley NA, Eyer P, Dawson AH. Management of acute organophosphorus pesticide poisoning. Lancet. 2008 Feb 16;371(9612):597-607. doi: 10.1016/S0140-6736(07)61202-1.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C028797	pralidoxime
D010091	Oximes

ID	Term
D006898	Hydroxylamines
D000588	Amines
D009930	Organic Chemicals